Multi-functional handheld optical coherence tomography imaging system

ABSTRACT

An OCT (Optical Coherence Tomography) handheld device is provided comprising: a housing configured for handheld OCT scanning during a surgical procedure, the housing comprising an OCT scanning end and a proximal end opposite the OCT scanning end; an OCT scanning device inside the housing, the OCT scanning device configured for one or more of OCT polarized scanning and Doppler OCT scanning from the OCT scanning end, the OCT scanning device further configured to receive and convey OCT light between the proximal end and an OCT analysing system; and a tip extending from the OCT scanning end, the tip being removably attached to the OCT scanning end, the tip configured to receive and collect the OCT light therethrough. The OCT handheld device is configured to be removably draped around the tip, for use in the surgical procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present specification claims priority from U.S. patent Ser. No.15/637,045, filed on Jun. 29, 2017, the entire contents of which isincorporated herein by reference.

FIELD

The specification relates generally to optical coherence tomography andspecifically to a multi-functional handheld optical coherence tomographyimaging system.

BACKGROUND

Optical Coherence Tomography (OCT) enables imaging of tissue to depthsof typically 1-2 mm due to the light absorption and scattering propertyof tissue. However, the majority of OCT systems are table top systemswhich require tissue to be removed from a patient for OCT scanning. Theprocess of removing tissue can cause severe damage to the patient,particularly when OCT scanning is to occur on human brain tissue.Furthermore, some OCT systems are purpose built for scanning particularbody parts, such as OCT systems built for scanning human eyes only, inwhich a patients' head must be placed on purpose-built head holder forscanning. Indeed, such requirements are generally due to the stabilityneeded to perform OCT scanning (e.g. the scanning tip and/or the tissuebeing scanned should be stable and/or lateral displacement duringscanning should be minimal). Such stability can be especially importantwhen performing Doppler OCT scanning and the like.

Such stability requirements can limit the usefulness of handheld OCTsystems, which are generally limited to intensity based OCT scans thatprovide only a single mode structural contrast of the tissue based onits optical scattering. These handheld OCT systems provide noinformation about the level of tissue organization and can have veryweak contrast on blood vessels. Neither do they give any quantitativeinformation on blood flow. Furthermore, tips of handheld OCT systems arealso too large to be inserted into a surgical opening and/or surgicalaccess port for scanning in a neuro-surgical procedure. In particular,such handheld OCT systems are not stable enough to perform Doppler OCTscanning. For this reason, there is no OCT scanning probe for usingsurgical access ports in neuro-surgical procedures. In fact, there areno such handheld OCT systems suitable for many surgical environments, assuch environments require that that medical devices used in surgery besterile, which is difficult to do with handheld medical devices ingeneral.

Some multi-contrast OCT systems can perform PS-OCT (polarizationsensitive OCT) scanning to determine tissue organization. However, thesesystems either do not have the capability of imaging blood flow (e.g.using Doppler OCT scanning) and/or the capability of imaging a tissue'soptical attenuation. While some of these systems also have PS-OCTimaging capability, stability issues again lead to poor scanningresults, for example, due to polarization fluctuations that occur withnon-polarization-maintaining fibers, for example, fiber movement, fiberstress and slight temperature changes. Hence, neither are such systemsthat are suitable for use in a clinical environment, suitable for use inan operating room. Furthermore, the tips and/or probes on these systemsare also too large to be inserted into the surgical opening and/orsurgical access ports used in neuro-surgical procedures.

SUMMARY

The present disclosure is generally directed to a handheld OCT deviceconfigured for one or more of OCT polarized scanning and Doppler OCTscanning, that is further configured for surgical draping, for examplefrom a removable tip. The tip is further made from material that is bothsterilisable and biocompatible, and can include a window, lens system,and the like. A surgical drape can be attached around an outercircumference of the tip, the surgical drape being sterilisable andconfigured to extend from the tip, over the handheld OCT device, andfurther over cables up to an OCT analyzing system. Hence, by attachingsuch a tip with a surgical drape to the OCT handheld device, the OCThandheld device can be rendered suitable for use in surgicalenvironments. Furthermore, as the tip is sterilisable and biocompatible,and can include a window, lens system, and the like, the tip can bepressed against tissue in a surgical environment to provide the desiredstability for performing one or more of OCT polarized scanning andDoppler OCT scanning. The tip can also be adapted for use with surgicalaccess ports by configuring the dimensions of the tip to be compatiblewith surgical access ports (e.g. insertable through surgical accessports).

Hence, the present disclosure is generally directed to image guidedmedical procedures using an access port. This port-based surgeryapproach allows a surgeon, or robotic surgical system, to perform asurgical procedure involving tumor resection in which the residual tumorremaining after is minimized, while also minimizing the trauma to theintact white and grey matter of the brain. In such procedures, traumamay occur, for example, due to contact with the access port, stress tothe brain matter, unintentional impact with surgical devices, and/oraccidental resection of healthy tissue.

An aspect of the specification provides an OCT (Optical CoherenceTomography) handheld device comprising: a housing configured forhandheld OCT scanning during a surgical procedure, the housingcomprising an OCT scanning end and a proximal end opposite the OCTscanning end; an OCT scanning device inside the housing, the OCTscanning device configured for one or more of OCT polarized scanning andDoppler OCT scanning from the OCT scanning end, the OCT scanning devicefurther configured to receive and convey OCT light between the proximalend and an OCT analysing system; and a tip extending from the OCTscanning end, the tip being removably attached to the OCT scanning end,the tip configured to receive and collect the OCT light therethrough,wherein the OCT handheld device is configured to be removably drapedaround the tip, for use in the surgical procedure.

In some implementations, the OCT handheld device further comprises asurgical drape attached around an outer circumference of the tip, thesurgical drape configured to extend from the tip, over the housing andpast the proximal end of the housing. In some implementations, thesurgical drape is further configured to extend from the tip over thehousing, past the proximal end, and over one or more cables extendingfrom the proximal end to the OCT analysing system.

In some implementations, the tip further comprises one or more of a lensand a lens system.

In some implementations, the tip is removably attached to the OCTscanning end using one or more of: a bayonet mount; and a twist and lockattachment mechanism.

In some implementations, the tip is formed from one or more materialsthat are both sterilisable and biocompatible.

In some implementations, the tip is between about 0.5 inches and about 3inches in length, and the tip has an outer diameter that is betweenabout 1 mm and about 15 mm.

In some implementations, the tip is between about 3 inches and about 15inches in length, and the tip has an outer diameter that is betweenabout 1 mm and about 10 mm.

In some implementations, the OCT scanning end is configured forremoveable attachment to one of a plurality of tips, each of theplurality of tips comprising a respective surgical drape attached arounda respective outer circumference, the respective surgical drapeconfigured to extend from a respective tip, over the housing and pastthe proximal end of the housing.

In some implementations, the OCT scanning device is further configuredfor polarized OCT scanning.

In some implementations, the OCT scanning device comprises one or moreof: an OCT light scanning device, an OCT light delivery apparatus, and alight polarizing apparatus.

In some implementations, the OCT scanning device comprises polarizationoptics configured to polarize the OCT light. In some implementations,the polarization optics comprises a quarter waveplate. In someimplementations, the OCT handheld device further comprises one or morepolarization-maintaining optical fibers configured to convey the OCTlight to and from the OCT analysing system.

In some implementations, the housing is configured to be held by a humanhand.

The OCT handheld device of claim 1, wherein housing comprises one ormore of a grip portion and slots, each configured for assisting a humanhand with holding the housing.

In some implementations, the housing is angled between the OCT scanningend and the proximal end.

In some implementations, the OCT handheld device further comprises atracking device.

BRIEF DESCRIPTIONS OF THE DRAWINGS

For a better understanding of the various implementations describedherein and to show more clearly how they may be carried into effect,reference will now be made, by way of example only, to the accompanyingdrawings in which:

FIG. 1 shows an example operating room setup for a minimally invasiveaccess port-based medical procedure, according to non-limitingimplementations.

FIG. 2 is a block diagram illustrating components of a medicalnavigation system that may be used to implement a surgical plan for aminimally invasive surgical procedure, according to non-limitingimplementations.

FIG. 3 depicts a block diagram illustrating components of a planningsystem used to plan a medical procedure that may then be implementedusing the navigation system of FIG. 2, according to non-limitingimplementations.

FIG. 4 depicts an example implementation port based brain surgery usinga video scope, according to non-limiting implementations.

FIG. 5 depicts insertion of an access port into a human brain, forproviding access to interior brain tissue during a medical procedure,according to non-limiting implementations.

FIG. 6 depicts an OCT (Optical Coherence Tomography) system thatincludes a handheld OCT device, according to non-limitingimplementations.

FIG. 7 depicts a block diagram of components of the OCT system of FIG.6, according to non-limiting implementations.

FIG. 8 depicts a block diagram of internal components of the handheldOCT device of FIG. 6, according to non-limiting implementations.

FIG. 9 depicts detail of a tip and a tissue scanning end of the handheldOCT device of FIG. 6, according to non-limiting implementations.

FIG. 10 depicts a tip with a surgical drape usable with the handheld OCTdevice of FIG. 6, according to non-limiting implementations.

FIG. 11 depicts various tips usable with the handheld OCT device of FIG.6, according to non-limiting implementations.

FIG. 12 depicts cross-sections of various tips usable with the handheldOCT device of FIG. 6, according to non-limiting implementations.

FIG. 13 depicts a prototype of a handheld OCT device in use, accordingto non-limiting implementations.

FIG. 14 depicts an en-face Doppler OCT image acquired using a prototypeof a handheld OCT device, according to non-limiting implementations.

FIG. 15 depicts a P-State Polarization en-face Doppler OCT imageacquired using a prototype of a handheld OCT device, according tonon-limiting implementations.

FIG. 16 depicts an S-State Polarization en-face Doppler OCT imageacquired using a prototype of a handheld OCT device, according tonon-limiting implementations.

FIG. 17 depicts the handheld OCT device of FIG. 6 in use with a devicepositioning system in a surgical environment, according to non-limitingimplementations.

FIG. 18 depicts a block diagram of a method for acquiring OCT imagesusing the system of FIG. 6, according to non-limiting implementations.

DETAILED DESCRIPTION

Various implementations and aspects of the specification will bedescribed with reference to details discussed below. The followingdescription and drawings are illustrative of the specification and arenot to be construed as limiting the specification. Numerous specificdetails are described to provide a thorough understanding of variousimplementations of the present specification. However, in certaininstances, well-known or conventional details are not described in orderto provide a concise discussion of implementations of the presentspecification.

The systems and methods described herein may be useful in the field ofneurosurgery, including oncological care, neurodegenerative disease,stroke, brain trauma and orthopedic surgery; however persons of skillwill appreciate the ability to extend these concepts to other conditionsor fields of medicine. It should be noted that the surgical process isapplicable to surgical procedures for brain, spine, knee and any othersuitable region of the body.

Various apparatuses and processes will be described below to provideexamples of implementations of the system disclosed herein. Noimplementation described below limits any claimed implementation and anyclaimed implementations may cover processes or apparatuses that differfrom those described below. The claimed implementations are not limitedto apparatuses or processes having all of the features of any oneapparatus or process described below or to features common to multipleor all of the apparatuses or processes described below. It is possiblethat an apparatus or process described below is not an implementation ofany claimed subject matter.

Furthermore, numerous specific details are set forth in order to providea thorough understanding of the implementations described herein.However, it will be understood by those skilled in the relevant artsthat the implementations described herein may be practiced without thesespecific details. In other instances, well-known methods, procedures andcomponents have not been described in detail so as not to obscure theimplementations described herein.

In this specification, elements may be described as “configured to”perform one or more functions or “configured for” such functions. Ingeneral, an element that is configured to perform or configured forperforming a function is enabled to perform the function, or is suitablefor performing the function, or is adapted to perform the function, oris operable to perform the function, or is otherwise capable ofperforming the function.

It is understood that for the purpose of this specification, language of“at least one of X, Y, and Z” and “one or more of X, Y and Z” may beconstrued as X only, Y only, Z only, or any combination of two or moreitems X, Y, and Z (e.g., XYZ, XY, YZ, ZZ, and the like). Similar logicmay be applied for two or more items in any occurrence of “at least one. . . ” and “one or more . . . ” language.

The terms “about”, “substantially”, “essentially”, “approximately”, andthe like, are defined as being “close to”, for example as understood bypersons of skill in the art. In some implementations, the terms areunderstood to be “within 10%,” in other implementations, “within 5%”, inyet further implementations, “within 1%”, and in yet furtherimplementations “within 0.5%”.

Referring to FIG. 1, a non-limiting example navigation system 100 isshown to support minimally invasive access port-based surgery. In FIG.1, a neurosurgeon 101 conducts a minimally invasive port-based surgeryon a patient 102 in an operating room (OR) environment. The navigationsystem 100 includes an equipment tower, tracking system, displays andtracked instruments to assist the surgeon 101 during the procedure. Anoperator 103 may also be present to operate, control and provideassistance for the navigation system 100.

Referring to FIG. 2, a block diagram is shown illustrating components ofan example medical navigation system 200, according to non-limitingimplementations. The medical navigation system 200 illustrates a contextin which a surgical plan including equipment (e.g., tool and material)tracking, such as that described herein, may be implemented. The medicalnavigation system 200 includes, but is not limited to, one or moremonitors 205, 211 for displaying a video image, an equipment tower 201,and a mechanical arm 202, which supports an optical scope 204. Theequipment tower 201 may be mounted on a frame (e.g., a rack or cart) andmay contain a computer or controller (examples provided with referenceto FIGS. 3 and 6 below), planning software, navigation software, a powersupply and software to manage the mechanical arm 202, and trackedinstruments. In one example non-limiting implementation, the equipmenttower 201 may comprise a single tower configuration with dual displaymonitors 211, 205, however other configurations may also exist (e.g.,dual tower, single display, etc.). Furthermore, the equipment tower 201may also be configured with a universal power supply (UPS) to providefor emergency power, in addition to a regular AC adapter power supply.

A patient's anatomy may be held in place by a holder. For example, in aneurosurgical procedure the patient's head may be held in place by ahead holder 217, and an access port 206 and an introducer 210 may beinserted into the patient's head. The introducer 210 may be trackedusing a tracking camera 213, which provides position information for thenavigation system 200. The tracking camera 213 may also be used to tracktools and/or materials used in the surgery, as described in more detailbelow. In one example non-limiting implementation, the tracking camera213 may comprise a 3D (three-dimensional) optical tracking stereocamera, similar to one made by Northern Digital Imaging (NDI),configured to locate reflective sphere tracking markers 212 in 3D space.In another example, the tracking camera 213 may comprise a magneticcamera, such as a field transmitter, where receiver coils are used tolocate objects in 3D space, as is also known in the art. Location dataof the mechanical arm 202 and access port 206 may be determined by thetracking camera 213 by detection of tracking markers 212 placed on thesetools, for example the introducer 210 and associated pointing tools.Tracking markers may also be placed on surgical tools or materials to betracked. The secondary display 205 may provide output of the trackingcamera 213. In one example non-limiting implementation, the output maybe shown in axial, sagittal and coronal views as part of a multi-viewdisplay.

As noted above with reference to FIG. 2, the introducer 210 may includetracking markers 212 for tracking. The tracking markers 212 may comprisereflective spheres in the case of an optical tracking system and/orpick-up coils in the case of an electromagnetic tracking system. Thetracking markers 212 may be detected by the tracking camera 213 andtheir respective positions are inferred by the tracking software.

As shown in FIG. 2, a guide clamp 218 (or more generally a guide) forholding the access port 206 may be provided. The guide clamp 218 mayoptionally engage and disengage with the access port 206 without needingto remove the access port 206 from the patient. In some examples, theaccess port 206 may be moveable relative to the guide clamp 218, whilein the guide clamp 218. For example, the access port 206 may be able toslide up and down (e.g., along the longitudinal axis of the access port206) relative to the guide clamp 218 while the guide clamp 218 is in aclosed position. A locking mechanism may be attached to or integratedwith the guide clamp 218, and may optionally be actuatable with onehand, as described further below. Furthermore, an articulated arm 219may be provided to hold the guide clamp 218. The articulated arm 219 mayhave up to six degrees of freedom to position the guide clamp 218. Thearticulated arm 219 may be lockable to fix its position and orientation,once a desired position is achieved. The articulated arm 219 may beattached or attachable to a point based on the patient head holder 217,or another suitable point (e.g., on another patient support, such as onthe surgical bed), to ensure that when locked in place, the guide clamp218 does not move relative to the patient's head.

Referring to FIG. 3, a block diagram is shown illustrating a control andprocessing unit 300 that may be used in the navigation system 200 ofFIG. 2 (e.g., as part of the equipment tower). In one examplenon-limiting implementation, control and processing unit 300 may includeone or more processors 302, a memory 304, a system bus 306, one or moreinput/output interfaces 308, a communications interface 310, and storagedevice 312. In particular, one or more processors 302 may comprise oneor more hardware processors and/or one or more microprocessors. Controland processing unit 300 may be interfaced with other external devices,such as tracking system 321, data storage device 342, and external userinput and output devices 344, which may include, but is not limited to,one or more of a display, keyboard, mouse, foot pedal, and microphoneand speaker. Data storage device 342 may comprise any suitable datastorage device, including, but not limited to a local and/or remotecomputing device (e.g. a computer, hard drive, digital media device,and/or server) having a database stored thereon. In the example shown inFIG. 3, data storage device 342 includes, but is not limited to,identification data 350 for identifying one or more medical instruments360 and configuration data 352 that associates customized configurationparameters with one or more medical instruments 360. Data storage device342 may also include, but is not limited to, preoperative image data 354and/or medical procedure planning data 356. Although data storage device342 is shown as a single device in FIG. 3, in other implementations,data storage device 342 may be provided as multiple storage devices.

Medical instruments 360 may be identifiable using control and processingunit 300. Medical instruments 360 may be connected to and controlled bycontrol and processing unit 300, and/or medical instruments 360 may beoperated and/or otherwise employed independent of control and processingunit 300. Tracking system 321 may be employed to track one or more ofmedical instruments 360 and spatially register the one or more trackedmedical instruments 360 to an intraoperative reference frame. In anotherexample, a sheath may be placed over a medical instrument 360 and thesheath may be connected to and controlled by control and processing unit300.

Control and processing unit 300 may also interface with a number ofconfigurable devices, and may intraoperatively reconfigure one or moreof such devices based on configuration parameters obtained fromconfiguration data 352. Examples of devices 320, as shown in FIG. 3,include, but are not limited, one or more external imaging devices 322,one or more illumination devices 324, a robotic arm 399, one or moreprojection devices 328, and one or more displays 305, 311.

Aspects of the specification may be implemented via processor(s) 302and/or memory 304. For example, the functionalities described herein maybe partially implemented via hardware logic in processor 302 andpartially using the instructions stored in memory 304, as one or moreprocessing modules 370 and/or processing engines. Example processingmodules include, but are not limited to, user interface engine 372,tracking module 374, motor controller 376, image processing engine 378,image registration engine 380, procedure planning engine 382, navigationengine 384, and context analysis module 386. While the exampleprocessing modules are shown separately in FIG. 3, in one examplenon-limiting implementation the processing modules 370 may be stored inthe memory 304 and the processing modules may be collectively referredto as processing modules 370.

It is to be understood that the system is not intended to be limited tothe components shown in FIG. 3. One or more components of the controland processing unit 300 may be provided as an external component ordevice. In one example non-limiting implementation, navigation engine384 may be provided as an external navigation system that is integratedwith control and processing unit 300.

Some implementations may be implemented using processor 302 withoutadditional instructions stored in memory 304. Some implementations maybe implemented using the instructions stored in memory 304 for executionby one or more general purpose microprocessors. Thus, the specificationis not limited to a specific configuration of hardware and/or software.

While some implementations may be implemented in fully functioningcomputers and computer systems, various implementations are capable ofbeing distributed as a computing product in a variety of forms and arecapable of being applied regardless of the particular type of machine orcomputer readable media used to actually effect the distribution.

At least some aspects disclosed may be embodied, at least in part, insoftware. That is, the techniques may be carried out in a computersystem or other data processing system in response to its processor,such as a microprocessor, executing sequences of instructions containedin a memory, such as read only memory (ROM), volatile random accessmemory (RAM), non-volatile memory, cache and/or a remote storage device.

A computer readable storage medium, and/or a non-transitory computerreadable storage medium, may be used to store software and data which,when executed by a data processing system, causes the system to performvarious methods. The executable software and data may be stored invarious places including for example ROM, volatile RAM, non-volatilememory and/or cache. Portions of this software and/or data may be storedin any one of these storage devices.

Examples of computer-readable storage media include, but are not limitedto, recordable and non-recordable type media such as volatile andnon-volatile memory devices, ROM, RAM, flash memory devices, floppy andother removable disks, magnetic disk storage media, optical storagemedia (e.g., compact discs (CDs), digital versatile disks (DVDs), etc.),among others. The instructions may be embodied in digital and analogcommunication links for electrical, optical, acoustical and/or otherforms of propagated signals, such as carrier waves, infrared signals,digital signals, and the like. The storage medium may comprise theinternet cloud, storage media therein, and/or a computer readablestorage medium and/or a non-transitory computer readable storage medium,including, but not limited to, a disc.

At least some of the methods described herein are capable of beingdistributed in a computer program product comprising a computer readablemedium that bears computer usable instructions for execution by one ormore processors, to perform aspects of the methods described. The mediummay be provided in various forms such as, but not limited to, one ormore diskettes, compact disks, tapes, chips, USB (Universal Serial Bus)keys, external hard drives, wire-line transmissions, satellitetransmissions, internet transmissions or downloads, magnetic andelectronic storage media, digital and analog signals, and the like. Thecomputer useable instructions may also be in various forms, includingcompiled and non-compiled code.

According to one aspect of the present application, one purpose of thenavigation system 200, which may include control and processing unit300, is to provide tools to a surgeon and/or a neurosurgeon that willlead to the most informed, least damaging neurosurgical operations. Inaddition to removal of brain tumours and intracranial hemorrhages (ICH),the navigation system 200 may also be applied to a brain biopsy, afunctional/deep-brain stimulation, a catheter/shunt placement procedure,open craniotomies, endonasal/skull-based/ENT, spine procedures, andother parts of the body such as breast biopsies, liver biopsies, etc.While several examples have been provided, aspects of the presentspecification may be applied to other suitable medical procedures.

Attention is next directed to FIG. 4 which depicts a non-limitingexample of a port-based brain surgery procedure using a video scope. InFIG. 4, operator 404, for example a surgeon, may align video scope 402to peer down port 406. Video scope 402 may be attached to an adjustablemechanical arm 410. Port 406 may have a tracking tool 408 attached to itwhere tracking tool 408 is tracked by a tracking camera of a navigationsystem.

Even though the video scope 402 may comprise an endoscope and/or amicroscope, these devices introduce optical and ergonomic limitationswhen the surgical procedure is conducted over a confined space andconducted over a prolonged period such as the case with minimallyinvasive brain surgery.

FIG. 5 illustrates the insertion of an access port 12 into a human brain10, in order to provide access to interior brain tissue during a medicalprocedure. In FIG. 5, access port 12 is inserted into a human brain 10,providing access to interior brain tissue. Access port 12 may include,but is not limited to, instruments such as catheters, surgical probes,and/or cylindrical ports such as the NICO BrainPath. Surgical tools andinstruments may then be inserted within a lumen of the access port 12 inorder to perform surgical, diagnostic or therapeutic procedures, such asresecting tumors as necessary. However, the present specificationapplies equally well to catheters, DBS needles, a biopsy procedure, andalso to biopsies and/or catheters in other medical procedures performedon other parts of the body.

In the example of a port-based surgery, a straight and/or linear accessport 12 is typically guided down a sulci path of the brain. Surgicalinstruments and/or surgical tools would then be inserted down the accessport 12.

Attention is next directed to FIG. 6, which depicts an example of asurgical OCT system that includes a handheld OCT device that could beused with the access port 12 and/or in open case surgery.

Specifically, FIG. 6 depicts an optical coherence tomography (OCT)system 600 comprising: a handheld OCT device 601 (interchangeablyreferred to hereafter as the device 601) in communication with an OCTanalyzing system 603 via one or more cables 605. The OCT analyzingsystem 603 comprises an OCT interferometer 607 and at least onecomputing device 609 configured to perform OCT analysis on OCT datareceived from the device 601. The system 600 further comprises at leastone display device 611 in communication with the computing device 609,at least one display device 611 configured to visually display OCTimages produced by the computing device 609, as described in furtherdetail below. The display device 611 can be part of the OCT analyzingsystem 603, or a separate component, for example a component of asurgical system, including, but not limited to OCT system 600. Indeed,the OCT analyzing system 603 can also be a component of the OCT system600. As such, the computing device 609 can be a component, for example,of the control and processing unit 300.

The device 601 comprises a housing 613 configured for handheld OCTscanning during a surgical procedure, the housing 613 comprising an OCTscanning end 615 and a proximal end 617 opposite the OCT scanning end615. The proximal end 617 may be alternatively referred to as an OCTsystem end as it is the end of the housing 613 that is in communicationwith the OCT analysing system 603 As will be described below withrespect to FIG. 8, the device 601 further comprises an OCT scanningdevice inside the housing, the OCT scanning device configured for one ormore of OCT polarized scanning and Doppler OCT scanning from the OCTscanning end 615, the OCT scanning device further configured to receiveand convey OCT light between the proximal end 617 and the OCT analysingsystem 603 (e.g. to and from the OCT interferometer 607). The device 601further comprises a tip 619 extending from the OCT scanning end 615, thetip 619 being removably attached to the OCT scanning end 615, forexample using an adaptor 620 at the OCT scanning end 615, the tip 619configured to receive and collect OCT light therethrough.

The device 601 is generally configured to be removably draped around thetip 619, for use in a surgical procedure. For example, as depicted, thedevice 601 further comprises a surgical drape 621 attached around anouter circumference of the tip 619, the surgical drape 621, as depicted,configured to extend from the tip 619, over the housing 613 and past theproximal end 617 of the housing 613. In particular, as depicted, thesurgical drape 621 is further configured to extend from the tip 619 overthe housing 613, past the proximal end 617, and over the one or morecables 605 extending from the proximal end 617 to the OCT analysingsystem 603. Hence, when the device 601 is used with the surgical drape621, and the tip 619 and the surgical drape 621 are both sterilized, thedevice 601 is quickly adaptable for use in a sterile surgicalenvironment without, for example, having to sterilize the housing 613,the one or more cables 605 etc. However, the device 601 can also be usedwith tips that do not include a surgical drape.

The device 601, as depicted, further comprises one or more buttons 623,and the like which, when actuated can initiate an OCT scan by the device601 and/or a mode of OCT scanning, for example one or more of OCTpolarized scanning and Doppler OCT scanning, and/or OCT scanning withoutpolarization or Doppler. In yet further implementations, actuation ofone or more buttons 623 can initiate a background removal mode, forexample to determine background noise which is removed in later OCTscans.

Attention is next directed to FIG. 7 which depicts a schematic blockdiagram of the system 600 with electrical, optical and data connectionsbetween the components depicted as different line types (e.g. dataconnections are depicted as solid lines, power connections are depictedas coarsely broken lines, and optical connections are depicted as finelybroken lines). As depicted, the system 600 further includes an isolationtransformer 701 that receives power from a main power supply, forexample via a wall plug, and the like, which supplies power to thecomputer 609, a power supply 702 for the OCT interferometer 607 and alaser 703 (which can be a component of the OCT interferometer 607 orseparate component). Furthermore, as depicted, the tip 619 ismechanically attached to the device 601. As depicted an optionaltracking device 704 is also mechanically attached to the device 601described in further detail below with respect to FIG. 17.

The OCT interferometer 607 is configured to provided OCT light to thedevice 601 via the one or more cables 605, the one or more cables 605including at least one optical fiber configured to convey OCT lightbetween the device 601 and the OCT interferometer 607 (e.g. the opticalconnection between the device 601 and the OCT interferometer 607depicted in FIG. 7). The OCT interferometer 607 may comprise a lightsource, such as the laser 703, or, as depicted, is in opticalcommunication with the laser 703 external to the OCT interferometer 607,via one or more optical couplers and/or beam splitters etc. The OCTinterferometer 607 includes a reference arm which may comprise at leasta reference mirror, and a detector. The laser 703 may be directed to anoptical coupler and/or beam splitter which splits the OCT light (e.g.laser light) into the reference arm and a sample arm of the OCTinterferometer 607. In the reference arm of the OCT interferometer 607,the OCT light is directed to a mirror that sets a reference imagingdistance from an optical coupler and/or beam splitter. The OCT lightthen reflects back to the optical coupler and/or beam splitter. In thesample arm, the optical coupler and/or beam splitter directs the OCTlight to the device 601 for use in an OCT scan through the tip 619.

In some implementations, described below, the device 601 includescomponents which polarize the OCT light and performs polarized OCTscanning (which can also be referred to as polarization-sensitive OCT(PS-OCT) scanning). As such, in these implementations, the at least oneoptical fiber of the one or more cables 605 includes at least onepolarization-maintaining (PM) optical fiber to convey polarized OCTlight to and from the OCT interferometer 607. Furthermore, in theseimplementations, the OCT interferometer 607 includes components thatanalyse the polarization states (e.g. the s-state and the p-state) ofthe OCT light received from the device 601. For example, the referencearm and the sample arm of the OCT interferometer can be adapted tointerfere the s-state OCT polarized light and the p-state OCT polarizedlight with reference s-state polarized light and reference p-statepolarized light, respectively.

Furthermore, the OCT scanning and/or a mode thereof, can be initiatedupon actuation of the one or more buttons 623. As a mode of OCT scanningcan, in some instances, depend on setting at the OCT interferometer 607and/or the computing device 609, the one or more cables 605 can includean electrical cable configured to relay data and/or signals indicativeof a mode of OCT scanning to the OCT interferometer 607 and/or thecomputing device 609.

In any event, OCT light that is emitted from the tip 619, and reflectedback through the tip 619, for example from tissue being scanned, isrelayed back through the device 601 to the OCT interferometer 607. Thereflected OCT light from device 601 and the reference mirror theninterferes (e.g. for each polarization state, when the reflected OCTlight is polarized) and forms a fringe pattern which creates an A-scanOCT signal through Fourier transform. The fringe pattern is converted todata using an imaging device, and the data is received at the computingdevice 609, which can convert the data into an image that is renderableat the display device 611 (assumed to be in communication with computingdevice 609 in FIG. 7, though not depicted). One such method forconverting the data to an image is described below with respect to FIG.18.

In some implementations, where the OCT light is not polarized by thedevice 601, the computing device 609 can produce OCT images with orwithout Doppler OCT analysis; in the case of Doppler OCT analysis, OCTscans from adjacent pixels are compared by the computing device 609 toproduce a Doppler OCT image. In some implementations where the OCT lightis polarized by the device 601, the computing device 609 can producepolarized OCT images for each of two polarization states (e.g. withoutDoppler OCT analysis). In some implementations where the OCT light ispolarized by the device 601, the computing device 609 can produceDoppler OCT images for each of the two polarization states. For example,the two polarization states can comprise a “p” polarization state and anorthogonal “s” polarization state. Different information can beextracted from Doppler OCT images, and polarization sensitive OCTretardance images (with or without Doppler).

Attention is next directed briefly back to FIG. 6 for further discussionof the device 601. In particular, the opposing ends 615, 617respectively comprise a distal end and a proximal end, with the proximalend 617 being an end that will be proximal a surgeon and the like, whensystem 600 is in use, and the distal end 615 being an end that will bedistal the surgeon, and/or directed towards tissue, a sample, a patientbeing operated on, and the like, when system 600 is in use. For example,the distal end 615 of the device 601 is an end distal a surgeon usingthe device 601.

In some implementations, the device 601 and the tip 619 may beconfigured to perform OCT scanning through a surgical access port.However, in other implementations, the the device 601 and the tip 619may be configured for use with one or more of an image guided medicalprocedure, and a minimally invasive procedure.

The device 601 may comprise one or more of an external handheld OCTdevice, an exoscope, and a device configured for use with a surgicalrobotic arm.

The housing 613 is generally configured to be held by a human hand, andhence is of a size and shape which is compatible with the device 601being held by a human hand. As such, the housing 613 is depicted asbeing ergonomically angled between the ends 615, 617, and furtherincludes one or more of a grip portion 625 and slots, each configuredfor assisting a human hand with holding the housing 613.

Furthermore, while not depicted, the housing 613 may include apositioner adapter configured to be held by an arm of a devicepositioner and/or a robotic arm, for example a component of a surgicalsystem, such that the arm may position the device 601 in relation to apatient being operated on, for example in relation to, and/or through,an access port and/or a surgical port. Such implementations arediscussed below with respect to FIG. 18.

In some implementations, the grip portion 625 is of a shape compatiblewith being held by an arm of a device positioner and/or a robotic arm.In other words, the device 601 may be held in place manually by asurgeon holding the device 601, or may be configured to be held by anarm of a surgical system.

Attention is next directed to FIG. 8 which depicts a schematic blockdiagram of components internal to the device 601, including the OCTscanning device 801. The device 601 comprises an electrical connector803 and an optical connector 805, removably attachable to the one ormore cables 605 (e.g. of FIG. 6); the electrical connector 803 and theoptical connector 805 can optionally be combined in a single connectorremovably attachable to the one or more cables 605. The electricalconnector 803 is connected to one or more electrical cables 807, and theoptical connector 805 is connected to one or more optical fibers 809including, but not limited to, one or more PM-optical fibers. Theelectrical connector 803 and the one or more electrical cables 807convey power and/or signals between the OCT interferometer 607 (and/orthe computing device 609 and/or the power supply 702) and electricalcomponents of the device 601, including, but not limited to, signalsindicative of an actuation of one or more of the buttons 623. Similarly,the optical connector 805, and the one or more optical fibers 809 conveyOCT light between the OCT interferometer 607 and optical components ofthe device 601, OCT light received from the OCT interferometer.

The one or more optical fibers 809 conveys OCT light received from theOCT interferometer 607 to collimating optics 808. Collimated OCT lightis emitted from the collimating optics 808 along an optical path 810.Indeed, the optical path 810 schematically indicates a path of OCT lightbetween the collimating optics 808 and the tip 619. In someimplementations, as depicted, the OCT light is polarized; in theseimplementations, the OCT scanning device 801 comprises polarizationoptics 811, in the path 810, the polarization optics 811 configured topolarize the OCT light. For example, the polarization optics 811 cancomprise a quarter wave plate.

While not depicted, in some implementations, the OCT scanning device 801further comprises a mechanical device (e.g. a stepper motor) for movingthe polarization optics 811 into and out of the path 810, for example,upon actuation of one or more of the buttons 623. Hence, in theseimplementations, the OCT light used for scanning is polarized or notpolarized depending on a position of the polarization optics 811.

The OCT light continues along the path 810 to a scanning device 813 anda focusing device 815, which are generally configured to scan and focusthe OCT light across tissue and/or a sample at the tip 619, as well asto collect light reflected from the tissue and/or the sample. Thescanning device 813 comprises one or more scanning components,including, but not limited to, an acousto-optic modulator, a MEMS(microelectromechanical) mirror and a galvanometer, such scanningcomponents configured to scan OCT light across a line and/or an area toobtain a one dimensional or two dimensional OCT image, respectively. Thefocusing device 815 comprises one or more lenses configured to focus theOCT light through the tip 619, as schematically indicated by thetriangular shape of the path 810 between the focusing device 815 and thetip 619. Indeed, as depicted, the tip 619 is mechanically connected tothe remainder of the device 601 via the adaptor 620.

In any event, OCT light reflected and/or scattered back from tissueand/or a sample at tip 619 is received back into the device 601 via thetip 619 and follows the path 810 back through the device 801 to the oneor more optical fibers 809, and out the optical connector 805 to the OCTinterferometer 607.

In any event, as is understood at least from FIG. 8, the OCT scanningdevice 801 comprises one or more of: an OCT light scanning device, anOCT light delivery apparatus, and a light polarizing apparatus.

Attention is next directed to FIG. 9 which depicts detail of the adapter620 and the tip 619. In particular, the tip 619 is removably attachableto the adapter 620 (e.g. the OCT scanning end 615) using one or more of:a bayonet mount; and a twist and lock attachment mechanism. For example,as depicted, the tip 619 is cylindrically shaped, at least at anattachment end (e.g. the end of the tip 619 that is to be attached tothe adapter 620), and the tip 619 further comprises tabs 919 extendingperpendicularly from the attachment end. The adapter 620 comprises slots920 that are complementary to the tabs 919 such that the tabs 919 can beattached to the slots 920 by pushing the tabs 919 into the slots andthen using a twist motion, as indicated by the arrows 950. Such aconfiguration of tabs 919 and slots 920 is referred to as a bayonetmount or, alternatively, as a twist and lock mechanism. While such abayonet mount is useful for quickly attaching and removing the tip 619to the device 601, especially when the surgical drape 621 extends fromthe tip 619, other attachment mechanisms are within the scope of presentimplementations, including, but not limited to, complementary threads ateach of an external surface of the tip 619 and an internal surface ofthe adapter 620.

It is understood that the adapter 620 can be a component that isattachable to the OCT scanning end 615 (e.g. to adapt the device 601 foruse with the tip 619), or the OCT scanning end 615 can be adapted toinclude the slots 920, for example the slots 920 can be integrated intothe OCT scanning end 615. Hence, the adapter 620 is generally optionalas long as the OCT scanning end 615 is adapted to include the slots 920and/or a complementary attachment device configured to removably receivea tip.

Attention is next directed to FIG. 10 which depicts the tip 619 with thesurgical drape 621 attached thereto, for example, bonded around an outercircumference of the tip 619 along a circumferential line 1021. Thebonding can occur using any suitable technique including, but notlimited to, heat bonding, glue, epoxies, and the like, assuming that theresulting combination of the tip 619 and the attached surgical drape 621is sterilisable and biocompatible.

Indeed, in some implementations, the combination of the tip 619 and thesurgical drape 621 can be provided and/or sold separately from theremainder of the device 601. Furthermore, the combination of the tip 619and the surgical drape 621 can be sterilized, and at least the tip 619is manufactured and/or formed from one or more materials that are bothsterilisable and biocompatible. For example, materials of the tip 619can include, but are not limited to, stainless steel, titanium, ABS-30i,and the like.

Similarly, the surgical drape 621 is generally manufactured and/orformed from one or more materials that are sterilisable including, butnot limited to, various transparent and/or semi-transparent drapableplastics. Furthermore, the surgical drape 621 is generally of a shapeand length that will fit over the device 601, along the one or morecables 605 to the OCT analysing system 603. Moreover, in someimplementations, the surgical drape 621 can be in multiple pieces inwhich a first piece is configured to fit over the device 601 and asecond piece is configured to fit over the cables 605; and the pieces ofthe surgical drape 621 can be connected using adhesives, tape, doublesided tape, and the like and/or any suitable connecting material and/orsealing means.

The combination of the tip 619 and the surgical drape 621 can besterilised and provided for a one-time use in a surgery, and/or thecombination of the tip 619 and the surgical drape 621 can be used once,and then re-sterilised for another use in a surgery. Either way,combinations of tips and surgical drapes can be sold and/or providedseparately from other components of the device 601.

In addition, the combination of the tip 619 and the surgical drape 621can be provided as one of a plurality of tips, and/or different types oftips, some of which include a surgical drape, while others do not.

For example, attention is next directed to FIG. 11 which depicts aplurality of tips, including the combination of the tip 619 and thesurgical drape 621, a combination of another tip 1119 and a respectivesurgical drape 1121, a tip 1129 without a surgical drape, and analternate tip 1139 without a surgical drape. Each of the tips 619, 1129are similar, other than the surgical drape 621 attached to the tip 619.The combination of the tip 1119 and the surgical drape 1121 is similarto the combination of the tip 619 and the surgical drape 621, other thana length and diameter of the tip 1119. For example, while an attachmentend of the tip 1119 is similar to the attachment end of the tip 619, theremainder of the tip 1119 has a smaller diameter and a longer length foruse, for example, for use with a surgical port and/or to access a deeperpart of a surgical field. In other words, the tip 619 may be used withopen case surgery, while the tip 1119 may be swapped onto the adapter620 to adapt the device 601 for use with a surgical port. Similarly, thetips 1119, 1139 can be used on skin in a diagnostic environment, with orwithout sterilization, for example on the surface of a patient's skin(e.g. not during surgery).

Hence a wide variety of shapes and sized of tips for the device 601 arewithin the scope of present implementations. For example, for use withopen case surgery, such tips can be between about 0.5 inches and about 3inches in length, and such tips can have an outer diameter that isbetween about 1 mm and about 15 mm (e.g. other than at an attachmentend). For use with surgical access ports, such tips can be between about3 inches and about 15 inches in length (e.g. longer than a surgicalaccess port with which such tips are to be used), and such tips can havean outer diameter that is between about 1 mm and about 10 mm (e.g. lessthan an inner diameter of a surgical access port with which such tipsare to be used).

However, the attachment ends of the tips 619, 1119, 1129, 1139 are allsimilar (e.g. similar tabs, similar diameters) such that the tips 619,1119, 1129, 1139 are all usable with the adapter 620. Put another way,the OCT scanning end 615 is configured (e.g. by way of the adapter 620and/or slots 920) for removeable attachment to one of a plurality oftips. In some implementations, each of the plurality of tips comprises arespective surgical drape attached around a respective outercircumference, the respective surgical drape configured to extend from arespective tip, over the housing 613 and past the proximal end 617 ofthe housing 613, for example to the OCT analysing system 603.

As depicted, each of the tips 619, 1119, 1129, 1139 are cylindrical inshape and can be hollow. However, the tips 619, 1119, 1129, 1139 caninclude windows, lenses, lens systems, and/or other types of opticalcomponents, and the like, internally.

For example, attention is next directed to FIG. 12 which depictscross-sections of other tips 1219 (having an attachment end 1220), 1229(having an attachment end 1230), 1239 (having an attachment end 1240),1249 (having an attachment end 1250), through a lateral cross-sectionthat includes respective tabs at a respective attachment end. The tips1219, 1229, 1239, 1249 are generally similar to the tips 619, 1129,however the tips 1219, 1229, 1239, 1249 each include optical components,for example at a respective tissue end (e.g. opposite a respectiveattachment end, the tissue end comprising the end of a tip thatinteracts with tissue and/or a sample) and/or internally.

For example, the tip 1219 includes a window 1251 transparent to OCTlight at a tissue end 1252. The tip 1229 includes a window 1261transparent to OCT light at a tissue end 1262, and a lens 1265 internalto the tip 1229, the lens 1265 configured to focus OCT light, forexample in conjunction with the focusing element 815. The tip 1239includes a lens 1271 transparent to OCT light at a tissue end 1272, thelens 1271 configured to focus OCT light, for example in conjunction withthe focusing element 815. The tip 1249 includes a lens 1281 transparentto OCT light at a tissue end 1282, and a lens 1285 internal to the tip1249; together the lenses 1281, 1285 form a lens system, the lens systemconfigured to focus OCT light, for example in conjunction with thefocusing element 815. It is appreciated that the windows 1251, 1261, andthe lenses 1271, 1281 are each formed from materials that are bothsterilisable and biocompatible as the windows 1251, 1261, and the lenses1271, 1281 may generally come into contact with tissue. The opticalcomponents internal to the tips are also sterilisable and, in someimplementations, also biocompatible; however, as the internal opticalcomponents may not come into contact with tissue, their biocompatibility(and their sterilisablitity) is less important then with the windows1251, 1261, and the lenses 1271, 1281.

Indeed, the tips 1219, 1229, 1239, 1249 depicted in FIG. 12 illustratethat a wide variety of tips, having various optical components, arewithin the scope of present implementations. Furthermore, other tips,having other optical components, will occur to persons of skill in theart and are within the scope of present implementations. For example, insome implementations, a tip usable with the device 601 is not hollow butfilled with an optically transparent material.

Furthermore, the windows 1251, 1261, and the lenses 1271, 1281, and thelike, provided at their respective tissue ends can be used to providestability to the device 601 when used, for example against tissue. Forexample, when the device 601 is held by a surgeon and pressed againsttissue, the windows 1251, 1261, and the lenses 1271, 1281, and the likeat the end of a tip can planarize the tissue (at least in the case ofthe windows 1251, 1261) and act as a stabilization area against whichthe surgeon can hold the device 601 steady, relative to the tissue.Indeed, use of a window, a lens, and the like, at a tissue end of any ofthe tips described herein can provide stability against bothmacro-movement, and micromovement, including, but not limited to,lateral movement, of the device 601, which can important when using thedevice in one or more of a polarization OCT scanning mode, and a DopplerOCT scanning mode.

For example, attention is next directed to FIG. 13 which depicts aprototype device 1301 in use performing OCT scanning of a pig's brain.The prototype device 1301 is similar to device 601, though with ahousing having a shape different from the housing 613; however, thedevice 1301 includes a tip 1319, similar to the tip 619, and a surgicaldrape 1321, similar to the surgical drape 621, extending from the tip1319, over the device 1301, and cables extending therefrom, for exampleto an OCT analyzing system. The device 1301 is not sterilized, otherthan the tip 1319, and the surgical drape 1321, and furthermore, thedevice 1301 successfully performs both polarization OCT scanning andDoppler OCT scanning, as described above, in an open case surgeryenvironment.

Indeed, attention is next directed to FIG. 14, FIG. 15, and FIG. 16which respectively depict: a Doppler OCT image 1401 obtained using adevice similar to the device 601 operated in a Doppler mode; aP-Polarization State Doppler image 1501 obtained using the deviceoperated in a polarization Doppler mode; and an S-Polarization StateDoppler image 1601 obtained using the device operated in thepolarization Doppler mode. Indeed, for each of the images 1401, 1501,1601, skin of a human being was scanned using the device while beinghand-operated. In any event, as each of the images 1401, 1501, 1601 isnot blurry, the images 1401, 1501, 1601 illustrate that devices usedherein can provide sufficient stability to perform Doppler OCT scanningand polarization OCT scanning using a handheld OCT device. Furthermore,different types of information are available in each of the images 1401,1501, 1601, for example, blood flow information, tissue organization andthe like.

Attention is next directed to FIG. 17 which schematically depicts thedevice 601 in use with a device positioning system 1701. In particular,a device positioning system 1701 includes a coupler 1705 configured tocouple to the device 601 to an arm 1706 of the device positioning system1701. Hence, while not depicted, device 601 may comprise one or moremechanical connectors and/or positioner adapters configured to attachthe device 601 to a mechanical arm of a surgical system, for examplethat includes device positioning system 1701. Furthermore, in someimplementations, the coupler 1705 is configured to hold the device 601by the grip portion 625.

As depicted, the surgical drape 621 covers the device 601, and thecoupler 1705 can couple to the device 601, for example through anaperture in the surgical drape 621. However, the surgical drape 621 maybe present or absent, as desired, for example according to thesterilization needs of the use of the device 601 with the devicepositioning system 1701. Either way, at least a tip 1719 of the device601 is sterilized, the tip 1719 being similar to the tip 619 butconfigured for use with a surgical access port 1712.

In particular, the device 601 is positioned with respect to a surgicalaccess port 1712 that has been placed in a patient 1713 (as with accessport 12 in FIG. 5), so that tissue therein is accessible. In particular,device positioning system 1701 may position the tip 1719 of the device601 into the surgical access port 1712. Hence, the robotic arm 1706 maybe controlled to position the tip 1719 into the surgical access port1712 so that device 601 may perform one or more OCT scans on tissue ofthe patient 1713; for example, while not depicted, the computing device609 may be in communication with the device positioning system 1701 andcontrol the device positioning system 1701 to position the tip 1719 intothe surgical access port 1712.

As depicted, the device 601 has been adapted to include a trackingdevice 1734, which can include, but is not limited, to the trackingdevice 704.

The tracking device 1734 is located at a proximal end of the device 601.Furthermore, the tracking device 1734 extends through the surgical drape621 (e.g. through an aperture therein).

The tracking device 1734 is generally configured to be tracked by asurgical navigation system, which can include, but is not limited to,components of the device positioning system 1701. The tracking device1734 is generally to extend away from the device 601 so that a camera,and the like, of the surgical navigation system may track a position ofthe tracking device 1734 and hence a position of the device 601. Asdepicted, the tracking device 1734 comprises four reflective spheresarranged in a configuration where each sphere is located at about acorner of a square. However, other numbers of spheres and otherconfigurations are within the scope of present implementations. Forexample, in some implementations, three or more of of such spheres maybe arranged and configured and/or selected to provide a given trackingaccuracy, including, but not limited to, a tracking accuracy that isless than about half a diameter of a sensing array surface. However, thetracking device 1734 may include tracking devices other than reflectivespheres. For example, in some implementations, the tracking device 1734may include a flexible sheath configured to measure tip positiondeflection, for example deflection of a tip of the flexible sheath.Furthermore, the device 601 may be adapted to include one or moretracking devices.

Attention is now directed to FIG. 18, which depicts a flowchart of amethod 1800 for generating OCT images using the system 600, according tonon-limiting implementations. In order to assist in the explanation ofthe method 1800, it will be assumed that the method 1800 is performedusing the computing device 609. Indeed, the method 1800 is one way inwhich the computing device 609 can be configured. Furthermore, thefollowing discussion of the method 1800 will lead to a furtherunderstanding of the system 600 and its various components. However, itis to be understood that the system 600 and/or the method 1800 can bevaried, and need not work exactly as discussed herein in conjunctionwith each other, and that such variations are within the scope ofpresent implementations. In other words, the method 1800 is one ofvarious techniques used to operate the system 600 to generate OCTimages, and other techniques are within the scope of the presentspecification.

Regardless, it is to be emphasized, that the method 1800 need not beperformed in the exact sequence as shown, unless otherwise indicated;and likewise various blocks may be performed in parallel rather than insequence; hence the elements of the method 1800 are referred to hereinas “blocks” rather than “steps”. It is also to be understood, however,that the method 1800 can be implemented on variations of the device 601as well. Furthermore, while the computing device 609 is described asimplementing and/or performing each block of the method 1800, it isappreciated that one or more blocks of the method 1800 occurs inconjunction with the device 601 and/or the OCT interferometer 607.

At a block 1802, the computing device 609 initiates OCT dataacquisition, for example for two polarization states (e.g. the s-stateand the p-state), by causing the device 601 and the OCT interferometer607 to perform OCT scanning using polarization optics 811 in the path810. The block 1802 can occur upon receipt of a signal from the device601 that indicates that one or more of the buttons 623 has beenactuated. Furthermore, in some implementations, the OCT signalacquisition comprises 50000 A-scans per second per location (e.g. foreach location of tissue scanned using the device 601), and for each ofthe polarization states. However, other numbers of A-scans per secondare within the scope of the present specification. Furthermore, theblock 1802 results in two polarization OCT data sets (e.g. an s-stateOCT data set and a p-state OCT data set).

At a block 1804, the computing device 609 digitizes the OCT dataacquired for each of the polarization data sets using, for example, 2048sampling points per A-Scan, however other numbers of sampling points arewithin the scope of the present specification.

At a block 1806, the computing device 609 resamples the digitized OCTdata of each of the polarization data sets, generated at the block 1804,for example, using k-clock sampling to resample evenly spaced points inthe digitized OCT data in the spatial frequency domain. In general,k-clock sampling comprises a sampling of points and/or locations in asignal, such that these points and/or locations are equally spaced inthe spatial frequency domain (e.g. as opposed to a wavelength domain ofthe signal).

At a block 1808, the computing device 609 optionally performs spectralshaping of each of the resampled digitized OCT data generated at theblock 1806, for each polarization data set, using, for example, a HannWindow, though other techniques for performing spectral shaping arewithin the scope of the present specification.

At a block 1810, the computing device 609 performs a fast Fouriertransform on each of the spectrally shaped resampled digitized OCT data,for each polarization data set.

The computing device 609 may implement blocks 1812-1816 to producePolarized Doppler OCT Images for each polarization data set using thetransformed spectrally shaped resampled digitized OCT data produced atthe block 1810 (e.g. as with images 1501, 1601); and/or the computingdevice 609 may implement blocks 1818-1820 to produce Polarized OCTImages (e.g. without Doppler) for each polarization data set using thetransformed spectrally shaped resampled digitized OCT data produced atthe block 1810.

For example, at block 1812, the computing device 609 performs a Dopplerphase shift calculation (e.g. using autocorrelation) using A-scans oftwo locations in the transformed spectrally shaped resampled digitizedOCT data produced at the block 1810. For example, phases of adjacentlocations in the spectrally shaped resampled digitized OCT data arecompared by autocorrelation to determine frequency phase shiftstherebetween. With typical A-scan averaging of, for example twolocations the resulting Doppler OCT data set has an effective scan rateof about half the scan rate used to acquire the OCT at the block 1802(e.g. if a scan rate of 50000 A-scans per second was used at the block1802, the effective scan rate of Doppler OCT data produced at the block1812 is 25000 A-scans per second). Furthermore, the Doppler phase shiftcalculations occur for each of the two polarization data sets.

At a block 1814, the computing device determines velocity differencesbetween each of the adjacent locations from the Doppler phase shiftsdetermined at the block 1812 for each of the polarization data sets, andproduces Polarized Doppler OCT images at the block 1816 for each of thepolarization data sets (e.g. similar to the images 1501, 1601). Theimages can be stored in a memory of the computing device 609, and/oroutput to the display device 611 for viewing by a surgeon, and the like,handling and/or using the device 601 (whether by hand, or via a devicepositioning system and the like).

Alternatively, and/or in addition to generating Polarized Doppler OCTimages, the computing device 609, can generate polarized structural OCTimages for each of the polarization data sets without Doppler analysis.In these implementations, at a block 1818, the computing device 609averages the transformed spectrally shaped resampled digitized OCT dataproduced at the block 1810 for each A-scan at each location scanned. Ata block 1820, the computing device 609 generates structural OCT imagesfor each of the polarization data sets from the averages produced at theblock 1818.

While not depicted, in some implementations, the method 1800 canoptionally include the computing device 609 generating non-polarizedDoppler OCT images (e.g. as in the image 1401) and/or non-polarizednon-Doppler OCT images (e.g. “traditional” OCT images).

While features of OCT systems and probes are described with reference tospecific implementations, features described with reference to oneimplementation of an OCT system and/or probe and/or device may be usedwith other implementations of OCT systems and/or probes and/or devices.For example, any of the OCT systems and/or probes and/or devicesdescribed herein may be adapted to include anti-reflective coatings,immersion materials, index matching materials, further tracking devices,and the like. Furthermore, while present implementations have beendescribed with reference to port-based surgery and open case surgery,present implementations may be used other types of surgery that is notport-based including, but not limited to open cranial surgery, and thelike.

Described herein is a handheld OCT device with various functions and/ormodalities, including polarized OCT scanning and/or Doppler OCTscanning, the handheld OCT device provided with stability using aremoveable tip. The tip can include a surgical drape extending therefromthat covers the handheld OCT device, and which can hence quickly adaptthe handheld OCT device for sterilized use in a surgical environment.

The specific embodiments described above have been shown by way ofexample, and it should be understood that these embodiments may besusceptible to various modifications and alternative forms. It should befurther understood that the claims are not intended to be limited to theparticular forms disclosed, but rather to cover all modifications,equivalents, and alternatives falling within the spirit and scope ofthis disclosure.

What is claimed is:
 1. An OCT (Optical Coherence Tomography) handhelddevice comprising: a housing comprising: a grip portion; a button toinitiate an OCT scan when actuated; an OCT scanning end; and a proximalend; an OCT scanning device, in the housing, to: perform the OCT scanfrom the OCT scanning end when the button is actuated; and receive andconvey OCT light between the proximal end and an OCT analyzing system;at least one cylindrical hollow tip, extending from the OCT scanningend, to collect the OCT light, and comprising: a tissue end to interactwith tissue during a surgical procedure; a lens internal to the at leastone cylindrical hollow tip, and to focus the OCT light; and, at thetissue end, an OCT light-transparent window to planarize the tissue andto mechanical stabilize the housing in relation to the tissue; at leastone adapter to removably couple the at least one cylindrical hollow tipwith the OCT scanning device; at least one surgical drape comprising: adistal portion to couple with an outer circumference portion of the atleast one cylindrical hollow tip; and a proximal portion, the at leastone surgical drape extending from the outer circumference portion, overthe at least one housing and beyond the proximal end of the housing tothe proximal portion; and at least one coupler to couple the OCTscanning device with a robotic arm of a device positioning systemthrough an aperture of the at least one surgical drape between thedistal portion and the proximal portion, wherein the at least onecylindrical hollow tip is removably coupled with the at least oneadapter by a bayonet mount.
 2. The OCT handheld device of claim 1,wherein the at least one surgical drape is further to extend over atleast one cable extending from the proximal end to the OCT analyzingsystem.
 3. The OCT handheld device of claim 1, wherein the at least onecylindrical hollow tip comprises a length in a range of approximately0.5 inch to approximately 3 inches.
 4. The OCT handheld device of claim1, wherein the at least one cylindrical hollow tip comprises an outerdiameter in a range of approximately 1 mm to approximately 15 mm.
 5. TheOCT handheld device of claim 1, wherein the at least one cylindricalhollow tip comprises a length in a range of approximately 3 inches toapproximately 15 inches in length.
 6. The OCT handheld device of claim1, wherein the at least one cylindrical hollow tip comprises an outerdiameter in a range of approximately 1 mm to approximately 10 mm.
 7. TheOCT handheld device of claim 1, wherein the OCT scanning device isfurther \ to perform polarized OCT scanning.
 8. The OCT handheld deviceof claim 1, wherein the OCT scanning device comprises at least one of:an OCT light scanning device, an OCT light delivery apparatus, and alight polarizing apparatus.
 9. The OCT handheld device of claim 1,wherein the OCT scanning device comprises polarization optics \ topolarize the OCT light.
 10. The OCT handheld device of claim 9, whereinthe polarization optics comprises a quarter waveplate.
 11. The OCThandheld device of claim 9, further comprising at least onepolarization-maintaining optical fiber to transmit and receive the OCTlight in relation to the OCT analyzing system.
 12. The OCT handhelddevice of claim 1, further comprising a tracking device.
 13. The OCThandheld device of claim 1, wherein at least one cylindrical hollow tipcomprises a plurality of cylindrical hollow tips.
 14. The OCT handhelddevice of claim 13, wherein each cylindrical hollow tip of the pluralityof cylindrical hollow tips comprises a distinct dimension in relation toanother cylindrical hollow tip of the plurality of cylindrical hollowtips.
 15. The OCT handheld device of claim 13, wherein each cylindricalhollow tip of the plurality of cylindrical hollow tips comprises adistinct shape in relation to another cylindrical hollow tip of theplurality of cylindrical hollow tips.
 16. The OCT handheld device ofclaim 1, wherein the window comprises a material that is at least one ofsterilizable and biocompatible.
 17. The OCT handheld device of claim 1,wherein the at least one cylindrical hollow tip comprises at least onematerial of: stainless steel, titanium, and ABS-30i, and wherein the atleast one cylindrical hollow tip comprises a material that is at leastone of sterilizable, biocompatible, and single-use.
 18. The OCT handhelddevice of claim 1, wherein each at least one cylindrical hollow tipfurther comprises a plurality of tabs radially extending perpendicularlyfrom an attachment end, wherein each at least one adapter comprises aplurality of slots to complementarily couple with the plurality of tabs,and wherein the plurality of the tabs are to couple with the pluralityof slots by: disposing the plurality of tabs in the plurality of slots;and twisting each at least one cylindrical hollow tip in relation toeach at least one adapter.
 19. The OCT handheld device of claim 1,wherein the at least one surgical drape comprises a plastic material,and wherein the at least one surgical drape is one of sterilizable andsingle-use.
 20. The OCT handheld device of claim 1, further comprising:at least one polarization-maintaining optical fiber to transmit andreceive the OCT light in relation to the OCT analyzing system; and atracking device, wherein the at least one surgical drape is further toextend over at least one cable extending from the proximal end to theOCT analyzing system, wherein the OCT scanning device is further toperform polarized OCT scanning, wherein the OCT scanning devicecomprises at least one of an OCT light scanning device, an OCT lightdelivery apparatus, and a light polarizing apparatus, wherein the OCTscanning device comprises polarization optics to polarize the OCT light,wherein the polarization optics comprises a quarter waveplate, whereinthe at least one cylindrical hollow tip comprises a plurality ofcylindrical hollow tips, wherein each cylindrical hollow tip of theplurality of cylindrical hollow tips comprises a distinct dimension inrelation to another cylindrical hollow tip of the plurality ofcylindrical hollow tips, wherein each cylindrical hollow tip of theplurality of cylindrical hollow tips comprises a distinct shape inrelation to another cylindrical hollow tip of the plurality ofcylindrical hollow tips, wherein the window comprises a material that isat least one of sterilizable and biocompatible, wherein the at least onecylindrical hollow tip comprises a material that is at least one ofsterilizable, biocompatible, and single-use, wherein each at least onecylindrical hollow tip further comprises a plurality of tabs radiallyextending perpendicularly from an attachment end, wherein each at leastone adapter comprises a plurality of slots to complementarily couplewith the plurality of tabs, wherein the plurality of the tabs are tocouple with the plurality of slots by: disposing the plurality of tabsin the plurality of slots; and twisting each at least one cylindricalhollow tip in relation to each at least one adapter, and wherein thesurgical procedure comprises a neurosurgical procedure.